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Yahoo
2 days ago
- Health
- Yahoo
US Health Secretary Kennedy guts vaccine advisory committee
By Ahmed Aboulenein, Michael Erman and Julie Steenhuysen WASHINGTON (Reuters) -Health Secretary Robert F. Kennedy Jr. has fired all 17 members of a U.S. Centers for Disease Control and Prevention panel of vaccine experts and is in the process of replacing them, his department said on Monday, drawing protest from many vaccine scientists. The move is the most far-reaching in a series of actions by Kennedy, a long-time vaccine skeptic, to reshape U.S. regulation of vaccines, food and medicine. Scientists and experts said the changes to the vaccine panel, which recommends how vaccines are used and by whom, would undermine public confidence in health agencies. Kennedy promised the move would raise public confidence. "Today we are prioritizing the restoration of public trust above any specific pro- or anti-vaccine agenda," Kennedy said in a statement from the Department of Health and Human Services. Kennedy has for years sown doubt about the safety and efficacy of vaccines, but he pledged to maintain the country's existing vaccine standards to secure his appointment in President Donald Trump's administration. The Food and Drug Administration, which is overseen by Kennedy's department, has approved a number of vaccines during his tenure despite concerns over his stances. Even so, at least one senior Republican member of Congress expressed doubts about the changes in the panel. Kennedy said the Advisory Committee on Immunization Practices is rife with conflicts and has never turned down a vaccine, even though the decision to approve vaccines rests with the U.S. Food and Drug Administration. The CDC panel provides guidance to the CDC on which groups of people would most benefit from an already-approved vaccine. "That's a tragedy," said former FDA Chief Scientist Jesse Goodman. "This is a highly professional group of scientists and physicians and others... It's the kind of political meddling that will reduce confidence rather than increase confidence." The Pharmaceutical Research and Manufacturers of America called Kennedy's action concerning for public health. "Upending the ACIP membership increases uncertainty and vaccine skepticism, undermining the health gains achieved through vaccination," the industry body said in a statement late on Monday. Shares of vaccine makers Moderna and U.S.-listed shares of BioNTech fell more than 1%, while Pfizer was down marginally in extended trading on Monday. Kennedy said most panel members receive funding from drugmakers although members are required to declare any potential or perceived conflicts of interest that arise in the course of their tenure and any relevant business interests, positions of authority or other connections with organizations relevant to the committee's work. Kennedy and HHS provided no specific evidence of industry conflicts of interest among departing ACIP members. The CDC's web page for conflicts of interest, last updated in March, showed that one current member had recused herself from votes on a handful of vaccines because she had worked on clinical trials for their manufacturers. BIDEN APPOINTEES All 17 ACIP members were appointed under former President Joe Biden's administration, including 13 in 2024, HHS said. Without their removal, Trump's administration would not have been able to choose a majority of the committee until 2028. "This is not a political committee, it's never been partisan," said Dorit Reiss, a vaccine law expert at UC Law San Francisco. "It's an expert committee. Presidents have never been involved in ACIP membership." The decision drew criticism from Democrats in Congress, and one key Republican expressed concern. "Of course, now the fear is that the ACIP will be filled up with people who know nothing about vaccines except suspicion," said Republican U.S. Senator Bill Cassidy in a post on X. "I've just spoken with Secretary Kennedy, and I'll continue to talk with him to ensure this is not the case." Cassidy, a doctor from Louisiana who had expressed wariness about Kennedy's anti-vaccine views before clearing the path for him to become the nation's top health official, said at the time he had received assurances Kennedy would protect existing vaccination programs. The CDC panel will convene its next meeting June 25-27 at CDC headquarters in Atlanta, the department said. Vetting new panel members typically takes months, said one expert with close ties to the committee, who expressed doubts the newly appointed panel would be able to meet on time unless Kennedy and his team "have been working in the shadows" to onboard them months ahead of the announcement. Kennedy has drawn condemnation from health officials for his vaccine policies including what they say is a weak endorsement of the measles shots during an outbreak that has infected more than 1,000 mostly unvaccinated people and killed three. He announced last month the government was dropping its recommendation that healthy children and pregnant women should receive COVID shots, sidestepping the typical process. Traditionally, once the FDA approves vaccines for sale to the public, ACIP's role is to review data in a public meeting and vote on vaccine recommendations, which are then sent to the CDC director to sign off. The Affordable Care Act generally requires insurers to cover vaccines that are listed on the CDC vaccine schedules for adults and children. The recommendations also determine which vaccines the CDC's Vaccines for Children program will provide free of charge to those without insurance.
Yahoo
01-05-2025
- Health
- Yahoo
US Health secretary Kennedy revives misleading claims of 'fetal debris' in measles shots
By Ahmed Aboulenein and Nancy Lapid WASHINGTON (Reuters) -U.S. health secretary Robert F. Kennedy Jr. reprised various misleading claims about vaccines this week, including that the measles vaccine contains cells from aborted fetuses and the mumps vaccination does not work. Kennedy's comments come as the U.S. battles one of its worst outbreaks of measles in 25 years. Scientists have warned that the U.S. is at a tipping point for the return of endemic measles, declared eradicated nationally in 2000, and say U.S. public health officials like Kennedy should provide urgent endorsement for highly effective vaccines. Two children have died and hundreds more have been infected in the outbreak in Texas, which is centered in a Mennonite community and has spread to neighboring states, including New Mexico, Oklahoma, and Kansas. Kennedy, who became the nation's top health official in February, has for decades helped sow doubts regarding the safety and efficacy of vaccines, contributing to a decline in vaccination rates. Kennedy says he is not opposed to vaccines, but has begun to revive some of the unproven or debunked theories he promoted as a lawyer and public figure, now from his perch at the U.S. Health and Human Services Department. "There are populations in our country, like the Mennonites in Texas, (who) were most afflicted, and they have religious objections to the vaccination, because the MMR vaccine contains a lot of aborted fetus debris and DNA particles, so they don't want to take it," he said in a News Nation interview on Wednesday. Kennedy was referring to the combined Measles, Mumps and Rubella vaccine. The vaccines do not contain "fetal debris" from abortions or intact fetal cells, vaccine experts said. The rubella portion of the vaccine is produced from a fetal cell line originating from an abortion that took place in the 1960s. The MMR vaccine does not contain the cells in its final form. The cells are derived from fetal cells that have been replicated over decades in test tubes in laboratory settings, thousands of times removed from the original ones. "The virus is grown in these cells, then this virus is purified, meaning everything other than the virus is filtered out, and all that's left is this attenuated virus that can't make you sick," said Dr. Miriam Laufer, Interim Director of the Center for Vaccine Development and Global Health at the University of Maryland. According to a fact sheet on how vaccines are made from the Children's Hospital of Philadelphia at the University of Pennsylvania, the amount of DNA involved in final vaccine preparation is minimal; billionths or trillionths of a gram. "While the final vaccines do not contain intact fetal cells, they may contain trace amounts of cell-derived materials, such as fragments of DNA," said Dr. Paulo Verardi, Professor of Virology and Vaccinology and the University of Connecticut. The Department of Health and Human Services did not respond to a request for comment. Kennedy also said this week that the mumps portion of the vaccine does not work and that there were safety concerns over it. "The problem is really with the mumps portion of the vaccine and the combination. That combination was never safety tested," he said on Monday at a live televised town hall event hosted by TV host Dr. Phil. Two doses of the MMR vaccine provide around 86% protection against mumps, according to the U.S. Centers for Disease Control and Prevention. While it is true that vaccine protection can wane over time, the rate varies depending on the disease and vaccine, Verardi and other vaccine experts said. "For mumps in particular, immunity can decline, so adults vaccinated in childhood may become susceptible again. Still, vaccinated individuals generally experience a milder illness if infected, which is still a key benefit of vaccination," he said.
Yahoo
04-04-2025
- Health
- Yahoo
Trump layoffs begin to erode FDA drug review system
By Ahmed Aboulenein, Julie Steenhuysen and Maggie Fick WASHINGTON (Reuters) -The Trump administration's mass firings at the U.S. Food and Drug Administration have removed employees critical to reviewing new medicines, setting back years of effort to bring promising treatments to patients more quickly, former and current FDA sources told Reuters. The FDA is slated to lose 3,500 employees under Secretary of Health and Human Services Robert F. Kennedy Jr.'s massive restructuring of U.S. health agencies that is part of President Donald Trump's wider campaign to dramatically slash the federal workforce. Staff began to receive termination notices on Tuesday, but it is unclear how many have been fired so far. Kennedy said last week that the main goal of the cuts was to centralize support functions such as technology, procurement, human resources and communications. Yet the personnel changes have included the ouster of high-ranking scientists at most major FDA divisions overseeing drugs and vaccines, medical devices, food, veterinary medicine and tobacco products. "These deep cuts and the loss of experienced leadership at virtually all the major centers that regulate the safety of food, drugs, devices is quite high risk," said Dr. Jesse Goodman, former chief scientist at the FDA and director of Georgetown University's Center on Medical Product Access, Safety and Stewardship. "If there is a safety issue with blood or a medical product or some vaccines, it's very important that you detect that and respond to it quickly, and it takes people who really understand it to do that," Goodman added. The firings this week also include all staff responsible for managing records – such as new product applications – at FDA divisions that oversee biotechnology therapies, medical devices, veterinary medicine and tobacco products, three sources said. The office that arranges travel for FDA inspectors who ensure factory production lines are meeting safety standards also was cut, three sources said. Employees directly tasked with reviewing new products appear to have been spared the layoffs, but four sources said they were aware of reviewers who were seeking new jobs outside of the agency due to the disruption. That prompted concerns over not having enough reviewers to participate in already scheduled meetings with pharmaceutical and device companies, as they would be required to recuse themselves from considering new products from an industry in which they might work. "The FDA will stay focused on ensuring the safety and efficacy of drugs, medical devices, food, and other critical sectors, and we will continue to meet our regulatory obligations with the integrity and urgency that the American people deserve," an HHS spokesperson said. Former FDA Commissioner Dr. Mark McClellan, now an economist at Duke University, however, said, significant reductions in staff "have the potential to compromise some of the very important FDA capabilities that have been built up over the last couple of decades." That is especially true of drugs developed with new mechanisms or through innovative approaches such as artificial intelligence or drugs intended for very rare diseases, he said. "I'm not sure all these reductions are going to stick because of those direct impacts that I don't think were intended," McClellan said. 'NO PLAN' Calley Means, a Kennedy ally and recently appointed White House adviser, rejected the idea that the layoffs would undermine public health. "It is insane for you to insinuate that the thing standing between us and better health is more government bureaucrats," Means said at Politico's Health Care Summit. The Senate Committee on Health, Education, Labor, and Pensions invited Kennedy to attend a hearing next week to explain the firings. The committee is chaired by Republican U.S. Senator Bill Cassidy of Louisiana, whose vote was key to Kennedy's confirmation. Cassidy initially showed hesitancy to confirm Kennedy, largely over the nominee's decades promoting theories on the dangers of vaccines contrary to scientific evidence. He said he ultimately agreed to vote for Kennedy after receiving assurances that existing vaccination programs would be protected. Asked by reporters on Wednesday whether Kennedy appears to be backsliding on his vaccine promises, Cassidy said: "We're in dialogue about that." Industry groups PhRMA and the Association for Affordable Medicines, which represent makers of branded and generic drugs, respectively, warned that dismissing key officials could hinder the availability of treatments to patients and stressed the importance of maintaining the FDA's expertise. Some FDA staffers questioned whether any of the firings were in error. Last month, medical device reviewers fired by Elon Musk's DOGE cost-cutting task force were quickly re-hired after the potential impact of their departures on product reviews became apparent. "They took all of the leadership out with no plan," said a recently terminated official in the FDA animal health division whose work involved addressing the threats of bird flu and antimicrobial resistance, among other functions. "My most optimistic theory is that some people in DOGE had no idea what they were cutting and they will ask us to come back in a couple of days," the official said. HHS said on Thursday that some laid off health agency employees will be asked to work remotely until June 2, when their administrative leave expires, while Kennedy said others may be reinstated, without providing details.
Yahoo
19-03-2025
- Health
- Yahoo
US Senate Democrats demand reversal of CDC mass firings
By Ahmed Aboulenein WASHINGTON (Reuters) -Seven U.S. Senate Democrats demanded on Wednesday that President Donald Trump's administration reinstate all of the employees it fired from the U.S. Centers for Disease Control and Prevention since he took office. The decision to fire hundreds of CDC employees has put the lives of Americans and other people across the world at risk, the senators wrote in a letter, seen by Reuters, to Secretary of Health and Human Services Robert F. Kennedy Jr. "Despite the CDC's critical responsibility and record of keeping Americans safe, one of your very first actions as Secretary was overseeing the firing of an estimated 750 public servants at CDC," they wrote. "We are deeply troubled by the complete disregard for public health and health promotion displayed by these mass firings." The letter, which was signed by Senators Raphael Warnock, Jon Ossoff, Ron Wyden, Chris Van Hollen, Ben Ray Lujan, Jeff Merkley, and Angela Alsobrooks, also demands Kennedy make clear to Congress how many CDC employees in total were fired since Trump took office and how many were reinstated. It also asks if any programs at the agency had been eliminated, what factors were considered when laying off staff, how the firings have affected public health preparedness, among other questions highlighting the opaque nature of the firings, part of a wider purge by Trump and billionaire Elon Musk of the federal bureaucracy that saw 25,000 people lose their jobs. A federal judge ruled last week that the mass firings were illegal and ordered workers reinstated. The Trump administration in court filings said that federal agencies were working to bring all of them back. "While we are encouraged to learn that some recently fired CDC employees have since been reinstated, we urge you to immediately reverse all firings, to reinstate all CDC personnel who were unfairly and recklessly terminated, and to halt all additional mass terminations at the CDC," the Senators wrote.
Yahoo
18-03-2025
- Health
- Yahoo
Trump administration weighing future of CDC's HIV prevention division
By Ahmed Aboulenein and Julie Steenhuysen WASHINGTON (Reuters) -The U.S. health department said on Tuesday it is reviewing the Centers for Disease Control and Prevention's HIV prevention division for overlap with other agencies but no final decision had been made about its future. The Department of Health and Human Services made the statement after the WSJ and NBC, citing unnamed sources, reported the division could be dismantled. The CDC's $1.3 billion Division of HIV Prevention is tasked with tracking infections across the United States and promoting testing and prevention, including the use of the HIV prevention medications, also known as PrEP. Carl Schmid, the executive director of the HIV+Hepatitis Policy Institute in Washington, told Reuters he had been told by a government agency source that the division might be shut down and that a decision would be made this week on the funding of HIV prevention at the CDC. Schmid, who co-chaired the Presidential Advisory Council of HIV/AIDS during President Donald Trump's first term, said he understood all of the division's funding is "up in the air". HHS, which oversees the CDC, said in a statement it was looking at all divisions for potential overlap as part of Trump's broader efforts to restructure the federal government and that no final decision had been made on the CDC's HIV Prevention Division. "If this decision is even made, this work would be continued elsewhere at HHS," a department official said. Another HHS agency, the Health Resources and Services Administration, contains the Ryan White HIV/AIDS Program which provides HIV health services to low-income people. The Trump administration's approach to HIV/AIDS policy is undergoing a broad shift. In January, the White House ordered an immediate halt to the distribution of HIV medications by U.S.-funded foreign clinics, disrupting treatment for millions worldwide. AIDS activists immediately began organizing a pressure campaign to try and preempt a potential decision on the division. Patient advocacy groups like AIDS United directed supporters to call elected representatives and provided sample scripts. "It is important that we get the message out that HIV prevention is important. The funding that the CDC's division of prevention gets is saving lives," said AIDS United CEO Jesse Milan. Moving HIV prevention services to a different health agency would likely involve significant cuts to the prevention portfolio, Milan added. "What is not well understood by decision makers is there are about 1.2 million people who are vulnerable to HIV infection," he said. "That is what the division is about. That is different from the 1.2 million people who already have HIV."
